An increased risk of a hard or ‘no deal Brexit?

24 Dec 2018

A ‘no deal’ Brexit will change and burden how all industries that move materials and goods across borders, including the pharmaceutical and medical device sectors, do business.

Pharmaceutical companies still do not know how they will be affected by Brexit after Prime Minister Theresa May decided to postpone a vote on her deal with the European Union (EU).

An increased risk of a hard or ‘no deal Brexit?

The delay was announced just a day before Parliament was due to decide whether to accept the draft framework agreement negotiated with the EU over the past 2 years. The deal as it currently stands faces strong opposition, and most observers had predicted it would not pass.

The vote, now set to take place in mid-January, would provide some clarity on how the development, manufacture and sale of pharmaceuticals and medical devices would be regulated after Brexit.

Whether the agreement can be renegotiated remains to be seen so at present there is an increased risk of a hard or ‘no deal Brexit where the UK potentially withdraws from the EU without a trading agreement.

A ‘no deal’ Brexit, if it happens – the European Court of Justice (ECJ) confirmed the UK can halt the Article 50 process unilaterally before 29 March – is predicted by many experts to risk huge social and economic impact.

It will also change and burden how all industries that move materials and goods across borders, including the pharmaceutical and medical device sectors, do business.

Supply chain disruption

Medicine supply chains between the UK and EU will be affected according to the Association for British Pharmaceutical Industries’ (ABPI) chief exective, Mike Thompson.

Writing in response to a government update he said: “Pharmaceutical companies continue to do everything in their power to make sure that patients get access to medicines whatever the Brexit scenario. This includes duplicating processes, changing supply routes and stockpiling medicines in line with the Government’s guidance. However, we have been clear that there are things which are out of our control.

“This update on potential border delays for 6 months in a ‘no deal’ scenario is stark. Stockpiling more medicines is not the solution to this problem,” Thompson continued, adding, “We welcome the Secretary of State’s intention to prioritise the flow of medicines and vaccines. But with just 16 weeks until the UK leaves the EU, we need the detail.”

He urged the Government to take immediate action to open up alternative supply routes between the UK and Europe and tell companies so they can make plans.

Third country controls

The UK BioIndustry Association raised similar concerns, noting the government has provided little information on actions it is planning beyond ensuring there is sufficient roll-on, roll-off freight capacity and that medicines will be prioritised on alternative routes.

It wrote: “A ‘no deal’ Brexit would mean the biggest dis-integration of the complex regulated medicines market across Europe in terms of regulation, cross border movement of goods, comparative pricing and intellectual property. The organisation also pointed out that many key parts of the UK’s future trading relationship will be decided in Brussels.

“The European Commission has made it clear that, in the event of a ‘no deal’ scenario, it will impose full third country controls on people and goods entering the EU from the UK. Whether this happens or not is in their hands, not ours,” it said.

Regulatory uncertainty

Regulations covering the development, manufacture and assessment of pharmaceutical products will also change under a ‘no-deal’ Brexit. It is not clear which EU rules will be written into UK law. For example, new on-pack safety feature regulations are likely to apply, but parts of the EU Clinical Trial Regulation (CTR) may not, according to the European Commission

Neither is it certain how the Medicines and Healthcare products Regulatory Agency (MHRA) will interact with the European Medicines Agency (EMA) with respect to, among other activities, manufacturing facility inspections.

Previously, the UK regulator has been very visible in Europe, ensuring that EU regulations have been pragmatic, favourable to innovation and forward-looking while protecting patient interests.

Other key questions remain regarding pharmacovigilance activities – which must take place in an EU member state or EEA territory – as well as batch release and certification.

RAPS is closely monitoring this period of uncertainty and transition and is committed to informing regulatory professionals with the latest news and insights as they develop.

Read More

Related tags

Top Stories Market News

Related news

India says shipments of hydroxychloroquine will resume after US exerts pressure

India says shipments of hydroxychloroquine will resume after US exerts pressure

7 Apr 2020

Our content has now moved to our new Global Pharma Insights website, providing the very latest news and information covering all aspects of the pharmaceutical supply chain. Please click the link below to access this article.

Read more 
Chinese CDMOs legislating for the future

Chinese CDMOs legislating for the future

2 Apr 2020

Our content has now moved to our new Global Pharma Insights website, providing the very latest news and information covering all aspects of the pharmaceutical supply chain. Please click the link below to access this article.

Read more 
FDA orders ranitidine withdrawal due to nitrosamine contamination risk

FDA orders ranitidine withdrawal due to nitrosamine contamination risk

2 Apr 2020

Our content has now moved to our new Global Pharma Insights website, providing the very latest news and information covering all aspects of the pharmaceutical supply chain. Please click the link below to access this article.

Read more 
China focused on meeting international API demand amid pandemic, say officials

China focused on meeting international API demand amid pandemic, say officials

1 Apr 2020

Our content has now moved to our new Global Pharma Insights website, providing the very latest news and information covering all aspects of the pharmaceutical supply chain. Please click the link below to access this article.

Read more 
CDMO Suven’s finished drug exports halted due to Indian COVID-19 lockdown

CDMO Suven’s finished drug exports halted due to Indian COVID-19 lockdown

25 Mar 2020

Indian contract development and manufacturing organisation, Suven Pharmaceuticals, has warned it cannot export finished products due to a shortage of raw materials following the country’s recent lockdown to fight the COVID-19 pandemic.

Read more 
2020 - a year for 'big answers' rather than 'big data'

2020 - a year for 'big answers' rather than 'big data'

7 Feb 2020

Zenith Technologies CEO, Joe Haugh, takes us through how the business has evolved this year, to better meet the needs of its customers, as well as the trends they see shaping the industry through 2020 and beyond.

Read more 
Inovio and Beijing Advaccine to advance vaccine against Coronavirus

Inovio and Beijing Advaccine to advance vaccine against Coronavirus

30 Jan 2020

Agreement will facilitate clinical trial translations in China.

Read more 
AstraZeneca embarks on $1bn zero carbon strategy

AstraZeneca embarks on $1bn zero carbon strategy

24 Jan 2020

The programme will include the launch of next-generation respiratory inhalers, which will use near-zero Global Warming Potential propellants.

Read more 
Diabetes diagnosis - now a matter of sweat and tears?

Diabetes diagnosis - now a matter of sweat and tears?

21 Jan 2020

No need to draw blood; researchers develop smart technology to diagnose diabetes and treat diabetic retinopathy.

Read more 
2019, the year that got serialization done!

2019, the year that got serialization done!

17 Dec 2019

The past 12 months have been busy as many companies fought to comply with serialization regulations.

Read more